MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; VESSEL SEALER

Model Number	410322-05
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted radical prostatectomy with lymphadenectomy surgical procedure, the vessel sealer (vs) instrument could not be used.A system message "instrument not connected to instrument control box" appeared on the vision side cart (vsc) monitor, and port indicator was illuminated red.The customer received phone assistance from the technical support engineer (tse).Tse had the customer perform the following steps: reseat the energy, activation and jumper cable, power cycle vio dv integrated electrosurgical unit (iesu) generator, and turn off the circuit breaker, but error code 32030 occurred.After this, the customer reported that the vs instrument jaws could not be opened while grasping the patient¿s tissue.The customer used an instrument release kit (irk) to open the jaws, but the issue was not resolved.Eventually, the assistant surgeon manually opened the vs jaws by using a laparoscopic instrument.The customer used a backup vs instrument to continue with the procedure.The procedure was continued with no reported injury.Isi followed up with the initial reporter and obtained the following additional information: the vs instrument was inspected prior to use with no issue.The vs instrument did not work at all during the procedure.The surgeon was performing tissue detachment on the kidney tissue.The follow up information indicated there was no unexpected bleeding or tissue removal.The procedure was completed with a backup vs instrument.There was no patient injury.
Additional Manufacturer Narrative
A return material authorization (rma) was issued to the customer requesting to have the intuitive device returned.However, isi has not received the product involved with the alleged issue to perform failure analysis.A follow-up mdr will be submitted if the product is returned (post failure analysis evaluation) or if additional information is received.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the vessel sealer (vs) instrument involved with this complaint and completed the device evaluation.Failure analysis did not replicate nor confirm the reported complaint.Visual inspection displayed no signs of physical damage.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The jaws opened and closed properly.There was no problem detected.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: VESSEL SEALER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 19160671
• Report Number: 2955842-2024-13583
• Device Sequence Number: 20665253
• Product Code: NAY
• UDI-Device Identifier: 10886874111113
• UDI-Public: (01)10886874111113(10)M10220502
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 410322-05
• Device Catalogue Number: 410322
• Device Lot Number: M10220502 146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/28/2024
• Supplement Date Received by Manufacturer: 07/08/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES.
• Patient Sex: Male